Timur Güvercini
Maquet Cardiopulmonary
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
Zielgruppe
Employees from companies, who are involved in medical devices process validation activities (developers, QM, manufacturing, Regulatory Affairs, etc.) are addressed. Of course, pharmaceutical companies which use medical devices as part of a combination product are addressed too as well as consultants in this field, who want to get information from the view of the medical device industry.
Zielsetzung
To show that a manufacturing process is reproducible is not only state of the art for medicinal products but also for medical devices. The regulatory requirements for process validation regarding medical devices are not as clear as those for medicinal products. There are very general requirements coming from ISO 13485 and from an old Global Harmonisation Task Force (GHTF) guideline dated 2004. Medical devices which are exported to the USA have to fulfil the process validation requirements from 21 CFR 820.75. But how to proceed process validaton in the medical devices industry today according to the state of the art that all requirements are met? Who is responsible for the process validation of medical devices? What documentation is necessary; what statistical indicators are helpful? Are there differences between medical devices and medicinal products? These questions will be discussed during the shortcut. Additionally, warning letter findings due to process validation will be presented.
Programm
The following issues will be discussed:
- Overview regulations: ISO 13485, GHTF Guideline Process Validation, 21 CFR 820.75
- What manufacturing types have to be validated (decision tree)?
- Who is responsible for process validation?
- Appropriate risk management techniques
- Validation protocol, record, report
- Statistical indicators
- Similarities and differences regarding medicinal product requirements
- Validation Life Cycle
- Revalidation vs Ongoing/Continued Process Verification
- Examples of FDA Warning Letter findings
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Mr Sven Pommeranz, +49 6221 84 44-47, pommeranz@concept-heidelberg.de
Questions regarding Organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Duration of the shortcut: 2h 8m
Recorded in May 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
